BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 11892067 · Received May 27, 2021

    Report

    Report Number
    2955842-2021-10569
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 3, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874121504
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D11 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT THAT "THE TIP OF THE NEEDLE DRIVER BROKE OFF IN THE PROCEDURE". THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.075" X 0.301" WAS FOUND TO BE BROKEN OFF AND THE BROKEN PIECE WAS RETURNED ALONG WITH THE INSTRUMENT. THE ROOT CAUSE OF BROKEN INSTRUMENT GRIPS IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D9, G3, G6, H2, H3, H6, AND H10. ANALYSIS INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10.

    Additional Manufacturer Narrative · 0

    BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1: B1 UPDATED FROM "PRODUCT PROBLEM" TO "ADVERSE EVENT AND PRODUCT PROBLEM". B2 UPDATED TO "REQUIRED INTERVENTION". H1 UPDATED FROM "MALFUNCTION" TO "SERIOUS INJURY".

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG FOR THE LARGE SUTURECUT NEEDLE DRIVER (PART # 471296-07/LOT/SERIAL# (B)(4)) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM SK0665. THERE WERE 0 USES REMAINING AFTER THIS LAST USAGE. IN ADDITION, A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THE INSTRUMENT AND OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS EVENT IS BEING REPORTED BECAUSE THE TIP OF THE LARGE SUTURECUT NEEDLE DRIVER REPORTEDLY BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENTS WERE RETRIEVED, AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENTS FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE LARGE SUTURECUT NEEDLE DRIVER WAS FOUND TO HAVE A TIP THAT BROKE OFF AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793889 ENDOWRIST LARGE SUTURE CUT NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 471296-07 N10201123 0176 00886874121504

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES